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CURE2h
FDA's ODAC Votes Against Targeted Therapies in Bladder and Prostate Cancer
The FDA’s ODAC has voted against the risk/benefit profile of two targeted therapies for the treatment of bladder and prostate ...
UroGen crashes as FDA AdCom rebukes bladder cancer drug
Shares of UroGen Pharma (NASDAQ:URGN) lost ~47% on Wednesday after an FDA advisory committee voted against the company’s ...
MedPage Today5h
FDA Panel Votes Against Broad Talazoparib-Enzalutamide Label in Prostate Cancer
An FDA advisory committee on Wednesday unanimously voted against recommending approval of the PARP inhibitor talazoparib ...
UroGen Pharma: ODAC Decision Puts Drug Approval In Limbo, But It's Not Over, Either
UroGen Pharma Ltd.'s investment thesis hinges on FDA approval of UGN-102. Click here to read more on URGN stock and its ...
Fierce Pharma5h
FDA advisors unanimously snub Pfizer's Talzenna in broader prostate cancer population
In a somber end to an FDA advisory committee’s two-day scouring of multiple drugmakers’ oncology data, Pfizer’s pitch to ...
Targeted Oncology1d
FDA ODAC Votes 4 to 5 Against UGN-102 for Recurrent LG-IR-NMIBC
The FDA ODAC decided that the overall benefit-risk of the investigational therapy UGN-102 is not favorable in patients with ...
Investing1d
FDA panel split on UroGen’s bladder cancer drug
UGN-102 is designed to be a non-surgical treatment for LG-IR-NMIBC, a condition currently lacking FDA-approved therapies ... efficacy of UGN-102, a bladder cancer drug, particularly its complete ...
Los Angeles Business Journal3d
FDA Delivers Blow to ImmunityBio
It’s a tale of two U.S. Food and Drug Administration decisions – one negative and the other positive – involving two different local immunotherapy ...